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An Open-Label, Multicenter Observational Study for Patients with Alzheimer’s Disease Treated with Memantine in the Clinical Practice

机译:美金刚在临床实践中对阿尔茨海默氏病患者进行的开放标签,多中心观察性研究

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Background/Aims: In this post-marketing observational study, the safety and effectiveness of memantine were evaluated in patients with Alzheimer’s disease (AD). Methods: In a 6-month, observational, open-label study at 202 specialist sites in Greece, the effectiveness of memantine was evaluated using the Mini-Mental State Examination (MMSE) and the Instrumental Activities of Daily Living (IADL) scale at baseline, and after 3 and 6 months. Discontinuation rates and adverse drug reactions (ADRs) were also recorded to evaluate the safety profile of memantine. Results: 2,570 patients participated in the study. Three and 6 months after baseline, MMSE and IADL scores were significantly improved compared to baseline. At the end of the study, 67% of the patients had improved their MMSE score; 7.1% of the patients reported ≧1 ADRs, and treatment was discontinued due to ADR in 0.7%. Conclusion: Memantine was well tolerated and had a positive effect on the patient’s cognitive and functional ability in real-life clinical practice, in agreement with randomized, controlled trials.
机译:背景/目的:在这项上市后的观察性研究中,评估了美金刚在阿尔茨海默氏病(AD)患者中的安全性和有效性。方法:在希腊的202个专业地点进行的为期6个月的开放性观察性研究中,使用最低精神状态检查(MMSE)和基线日常工具活动量(IADL)量表评估了美金刚的有效性,以及3个月和6个月之后。还记录了停药率和药物不良反应(ADR),以评估美金刚的安全性。结果:2570名患者参加了研究。基线后三个月和六个月,与基线相比,MMSE和IADL评分显着提高。在研究结束时,67%的患者的MMSE评分得到改善; 7.1%的患者报告了ADR≥1,并且由于0.7%的ADR而终止治疗。结论:与随机对照试验一致,美金刚胺在现实生活中具有良好的耐受性,并且对患者的认知和功能能力具有积极作用。

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